Phase II Dose Titration Study in Patients With Neuropathic Pain
NCT ID: NCT00736151
Last Updated: 2009-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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1
Ralfinamide administered orally at rising doses of 80 - 320 mg/day
Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
2
Placebo controlled with randomization of 2:1
Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
Interventions
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Ralfinamide
Oral tablets administered at rising doses of 80 - 320 mg/day
Eligibility Criteria
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Inclusion Criteria
* Females post-menopausal for at least 12 months, 24 months in India, Poland, and Austria
* Diagnosed by neurologist with current neuropathic pain
18 Years
85 Years
ALL
No
Sponsors
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Newron Pharmaceuticals SPA
INDUSTRY
Responsible Party
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Newron Pharmaceuticals S.p.A
Locations
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Universitatsklinik Fur Neurologie
Graz, , Austria
Universitatsklinik Fur Neurologie
Innsbruck, , Austria
LKH
Klagenfurt, , Austria
General Hospital AKH
Vienna, , Austria
Fakultni nemocnice u svate' Anny v Brne
Brno, , Czechia
Fakultni nemocnice Brno
Brno-Bhunice, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Univercity Hospital Pilsen
Pizen, , Czechia
Fakultni Thomayerova nemocnices poliklinikou
Prague, , Czechia
Na Homolce Hospital
Prague, , Czechia
Neurology Centre
Ahmedabad, , India
M.S. Ramaiah Medical
Bangalore, , India
R.S. R'S Trinity Acute Care Hospital
Chennai, , India
Sri Ramachandra medical College
Chennai, , India
Care Hospital
Hyderabad, , India
Chowpatty Medical Centre
Mumbai, , India
Brain and Mind Institute
Nagpur, , India
Apollo Hospital
Pradesh, , India
Brain Waves Clinic
Pune, , India
Vijaya Health Centre
Vadapalani, , India
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Ce. S.I. Fondazione Universitaria
Chieti, , Italy
Ospedale Clinicizzato Universitario SS. Annunziata
Chieti, , Italy
Arcispedale Sant'Anna
Ferrara, , Italy
Azienda Ospedaliera San Martino
Genova, , Italy
Universita degli Studi di Genova
Genova, , Italy
Ospedale Luigi Sacco
Grassi, , Italy
Ospedale Civile Umberto I
Mestre, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Scientifico di Riabilazione di Montescano
Montescano, , Italy
Policlinico Universitario Federico II
Napoli, , Italy
UCADH
Pavia, , Italy
Presidio Ospedaliero Monteluce
Perugia, , Italy
Universita degli Studi di Roma
Roma, , Italy
Policlinico G.B. Rossi
Verona, , Italy
Centrum Medyczne Osteomed
Bialobrzeska, , Poland
Centrum Kliniczno Badawcze
Elblag, , Poland
Wojewodzki Szpiyal Spejalistyczny
Gdansk, , Poland
Center Of Clinical Neurology
Krakow, , Poland
Osrodek Baden Klinicznych
Lublin, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Wroclaw Medical University
Wroclaw, , Poland
Oddzial Neurologiczny
Zgierz, , Poland
Gartnavel General Hospital
Glasgow, , United Kingdom
Barta and The London NHS Trust
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Solihull Hospital
West Midlands, , United Kingdom
Countries
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Other Identifiers
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NW-1029/001/II/2003
Identifier Type: -
Identifier Source: org_study_id
EUDRACT Number 2004-000557-35
Identifier Type: -
Identifier Source: secondary_id
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